Drug Safety Information for FLUTICASONE PROPIONATE (Fluticasone propionate)

Safety-related Labeling Changes for CUTIVATE (FLUTICASONE PROPIONATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FLONASE (FLUTICASONE PROPIONATE) Over-the-counter Drug: FDA Link

Safety-related Labeling Changes for FLOVENT DISKUS 100 (FLUTICASONE PROPIONATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ADVAIR DISKUS 100/50 (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ADVAIR HFA (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FLOVENT HFA (FLUTICASONE PROPIONATE) Rx Drug: FDA Link

Safety-related Labeling Changes for AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for XHANCE (FLUTICASONE PROPIONATE) Rx Drug: FDA Link

Adverse Drug Reactions for FLUTICASONE PROPIONATE* (Fluticasone propionate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with FLUTICASONE PROPIONATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective3903
2Dyspnoea3710
3Nausea2249
4Product quality issue2188
5Headache*2139
6Fatigue2062
7Asthma1943
8Cough*1865
9Pain1844
10Dizziness*1819
11Pneumonia1564
12Diarrhoea1505
13Vomiting1381
14Anxiety*1367
15Asthenia1296
16Malaise1240
17Chest pain1170
18Pyrexia1097
19Fall1096
20Arthralgia1091

* This side effect also appears in "Top 10 Side Effects of FLUTICASONE PROPIONATE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking FLUTICASONE PROPIONATE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication23210
2Asthma*16981
3Hypersensitivity*7773
4Chronic obstructive pulmonary disease4485
5Multiple allergies2493
6Seasonal allergy*2214
7Rhinitis allergic*2106
8Sinus disorder1035
9Dyspnoea953
10Nasal congestion*916

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for FLUTICASONE PROPIONATE

Total Reports Filed with FDA: 196743


Number of FDA Adverse Event Reports by Patient Age for FLUTICASONE PROPIONATE

Total Reports Filed with FDA: 196743*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluticasone propionate (Flovent diskus 50, Flovent diskus 250, Fluticasone, Fluticasona, Floventhfa, Flovent diskus 100, Flovent, Cutivate, Flovent hfa, Flonase)

Charts are based on 196743 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and FLUTICASONE PROPIONATE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.